Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.

Launched by NOVARTIS PHARMACEUTICALS · Sep 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called remibrutinib for adults with chronic spontaneous urticaria (CSU), a condition that causes itchy hives. The trial will compare remibrutinib to a placebo (an inactive treatment) and to another medication called omalizumab, which is already used to help manage CSU. The initial phase of the study lasts 24 weeks, where participants will take either remibrutinib or the other treatments to see how well they work and how safe they are. After this, there’s an optional 52-week extension for those who continue with remibrutinib, allowing researchers to gather more information about its long-term effects.

To participate, individuals should be 18 years or older and have had CSU for at least six months, which hasn’t been well-controlled with standard antihistamines. Participants need to keep a daily diary about their symptoms during the study. It’s important to know that people who have previously used certain other treatments for CSU or have specific health issues may not be eligible. If you or a loved one are considering joining this trial, it could be a chance to access a new treatment while contributing to important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female adult participants ≥18 years of age at the time of signing the informed consent.
• • CSU duration for ≥ 6 months prior to screening.
• * Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of randomization, defined as:
• • The presence of itch and hives for ≥6 consecutive weeks prior to screening, despite the use of second-generation H1-AH during this time period.
• • UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0- 21) ≥ 6 during the 7 days prior to randomization (Day 1).
• • Documentation of hives within three months before randomization.
• • Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.
• • Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1).
• Exclusion Criteria:
• • Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies.
• • Significant bleeding risk or coagulation disorders.
• • History of gastrointestinal bleeding.
• • Requirement for anti-platelet or anti-coagulant medication.
• • History or current hepatic disease.
• • Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
• • Evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines.
• • Documented history of anaphylaxis.
• • Pregnant or nursing (lactating) women.